This invention relates to a sterile cover for an ultrasonic probe inserted through the outer integument of the body, as well as a method and a kit for providing the cover.
There is now in existence ultrasonic diagnostic equipment for providing images of tissue in organs within the body. Basically, this equipment operates by transmitting high frequency pulses of sound into the body, detecting the pattern of reflection of this sonic energy, and translating this information into a visual image. The advantage of this technique is that the images of the tissue or organs inside the body can be obtained without disrupting the integrity of the body.
More recently, it has been found that better images can be obtained if the sonic probe or transducer of the equipment is inserted through the outer integument of the body. Ultrasonic diagnostic probes have been designed for insertion through the skin of the patient and, in the case when an image of the brain is desired, even through the skull. When such a probe is used, it is necessary that the procedure be carried out under asceptic conditions and that the sterility of the probe, the connecting cable, and all persons and other devices coming into actual or approximate contact with the probe must be maintained. One way that sterility has been maintained is to sterilize the probe and the cable after each use, but this technique is not practical. The sterilization procedure, including the necessary controls to ensure the effectiveness of the sterilization procedure, requires one to eight days. Of course, during this sterilization period, no further diagnoses can be made with the probe. This problem can be avoided by the use of multiple substitute probes, but the probes themselves cost over $10,000.00 each and most hospitals cannot afford to purchase a large number. Another inadequate solution to the problem of sterilization has been to cover the probe and cable in whatever sterile materials are available, such as surgical gloves. Thus, there is a need in the art for an effective, convenient, and inexpensive way to provide for and maintain the sterilization of sonic probes and connecting cables.